Open Fracture
Conditions
Keywords
open fracture
Brief summary
To evaluate the feasibility, safety, and potential efficacy of applying vancomycin powder locally to open fractures in the emergency department prior to definitive surgical intervention.
Interventions
A single 1-gram dose of sterile vancomycin powder is applied directly to the open fracture wound in the Emergency Department after initial wound assessment and irrigation and prior to definitive operative debridement and fixation.
OTHERStandard Open Fracture Care
Standard management of open fractures according to institutional protocols, including intravenous antibiotics, wound care, irrigation, operative debridement, and fracture stabilization as indicated, without topical vancomycin powder application in the Emergency Department.
Sponsors
Atlantic Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants aged 18 years or older presenting to the Emergency Department with Gustilo-Anderson Type I, II, or III open fractures.
Exclusion criteria
* Known allergy to vancomycin * Ballistic open fractures * Pregnancy * Currently breastfeeding * Age younger than 18 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Deep Surgical Site Infection | Defined as the proportion of participants who develop a deep surgical site infection involving the open fracture site within 90 days of injury or index operative treatment. | Incidence of deep surgical site infection following open fracture treatment, defined according to Centers for Disease Control and Prevention (CDC)/National Healthcare Safety Network (NHSN) criteria and/or requiring operative irrigation and debridement or deep culture-directed antibiotic treatment. |
Countries
United States
Contacts
CONTACTKristen De Wilde MD
Outcome results
None listed